(74 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.
Device Name: Zibo Yingjie Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K101565)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (Zibo Yingjie Medical Products Gloves) | Standard / Test Method |
|---|---|---|
| Physical and Dimensions Testing | Meets requirements | ASTM Standard D5250-06 |
| Water Fill Test (Pinhole integrity) | Meets requirements (AQL 2.5, Inspection Level I) | FDA 1000 ml. Water Fill Test |
| Primary Skin Irritation | No primary skin irritant reactions | Biocompatibility testing |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions | Biocompatibility testing |
| Powder-Free Claim (max 2 mg powder per glove) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) | Testing conducted to ensure compliance |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for pinholes, or how many subjects for biocompatibility).
The data provenance is from non-clinical tests conducted by Zibo Yingjie Medical Products Co., Ltd. in China (Zibo, Shandong). The tests are prospective, as they are performed to demonstrate compliance for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes the testing of a medical device (patient examination gloves) through physical and chemical property assessments based on established standards, rather than expert interpretation of medical images or data. Ground truth for these types of devices is based on objective measurements against defined specifications within recognized standards (e.g., ASTM, FDA regulations).
4. Adjudication Method for the Test Set
This information is not applicable as adjudication methods (like 2+1 or 3+1) are typically used in studies involving human interpretation or subjective assessments, such as evaluating medical images. The tests for these gloves are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often to compare AI-assisted performance with unassisted performance. This device is a disposable medical glove, and its performance is evaluated through physical and chemical testing against established standards, not through human reader interpretation of outputs.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical glove, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate. The device itself is evaluated in a standalone manner against physical and chemical specifications.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Established standards and specifications: Specifically, ASTM Standard D5250-06 for physical and dimensional properties, and FDA requirements for pinhole integrity.
- Biocompatibility testing results: Demonstrating no primary skin irritation or sensitization reactions.
- Quantitative measurements: For powder content (no more than 2 mg per glove).
These are objective, quantifiable criteria defined by regulatory bodies and consensus standards, not subjective expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic device study.
8. The Sample Size for the Training Set
This information is not applicable. The device is a manufactured product (gloves) and does not involve a "training set" in the context of machine learning algorithms or statistical models that require data to be trained. The manufacturing process is subject to quality control and adherence to specifications, but not a "training set" like that seen in AI/ML development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. There is no training set for this device.
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510 (K) SUMMARY
AUG 1 7 2010
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
1. Submitter's Identification:
Zibo Yingjie Medical Products Co., Ltd. No. 8 West the Fifth Road Zhangdian District, Zibo, Shandong, China
Date summary prepared: June 3, 2010
2. Name of the Device:
Zibo Yingjie Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free
3. Predicate Device Informaton:
Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Comparison to Predicate Devices: 6.
Zibo Yingiie Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. and Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Powder free.
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Discussion of Non-Clinical tests performed for Determination of 7. Substantial Equivalence are as follows:
The standards used for Zibo Yingjie Medical Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization. reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is no hypoallergenic claim.
Conclusions:
Zibo Yingjie Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free conform fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zibio Yingjie Medical Products Company, Limited C/O Mr. Frank Liu Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
AUG 17 2010
Re: K101565
Trade/Device Name: Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Non Colored Regulation Number: 21 CFR 880.6250 . Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 3, 2010 Received: June 4, 2010
Dear Mr. Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Liu
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh. for.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K10)S6 5
Zibo Yinqjie Medical Products Co., Ltd.
No. 8 West the Fifth Road, Zhangdian District, Zibo, China 255414
INDICATIONS FOR USE
Applicant:
Zibo Yingjie Medical Products Co., Ltd. K101565
Device Name:
510(k) Number:
Patient Vinyl Examination Gloves, Powder free, Non-Sterile, Non Colored
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use
Over the Counter Use X
Factory Initials
Elaine S. Mayhall for Elizabeth Clark
(Division Sign-Off)
(Division Sign-Up)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.